MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Blood Loss (2597)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scarring or skin discoloration).

Event Description

Dexcom was made aware on 07/13/2016 that the patient experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.The reaction described the reaction as a rash that scabs up and bleeds, located underneath the sensor pod.On (b)(6) 2016, the patient saw his doctor regarding the rash and dark spots created by the sensor on the abdomen.Affected area was treated with over-the-counter cocoa butter.At the time of contact, the patient was not wearing the sensor due to site issues but planned to restart use of the sensor on (b)(6) 2016.No additional event or patient information was provided.No product or data was returned for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5870450
• MDR Text Key: 51922203
• Report Number: 3004753838-2016-80019
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 129